Three Methods Used in the Diagnosis of EER in Children With OME

Otitis Media With Effusion Clinical Trial

Official title:

Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183961
• Other study ID #: FNO-ENT-EER Peptest Restech
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: July 2, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.

Description:

Children aged between 1 and 7 years diagnosed with bilateral or unilateral OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in the prospective study. OME was defined as effusion in the middle ear behind an intact eardrum for longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings, pneumatic otoscopy, type B tympanometry and audiometry (in older, cooperative children). Children with no fluid in the middle ear during myringotomy were re-diagnosed as having tympanosclerosis and were excluded from the study. Children with craniofacial abnormalities (Down syndrome, Treacher Collins syndrome, clefts etc.) were excluded from the study as well. Demographic data and symptoms of EER disease were provided by parents, who were specifically asked about hoarseness, recurrent lower respiratory infections (bronchitis, pneumonia) and bronchial asthma in their child.

24 hour monitoring of oropharyngeal pH using the Restech system was performed before surgery. Parents were instructed to record the time their child spent eating, drinking and in a horizontal position directly to the device and manually to the diary. If there was any discrepancy, periods logged in the device were modified according to the diary. A standardized RYAN composite score was calculated automatically using the software supplied. Patients with pathological RYAN composite scores in the vertical (higher than 9.4) and/or horizontal (higher than 6.8) position were classified as having pathological EER. Severe EER was diagnosed when the RYAN composite score in the vertical or horizontal position was higher than 200.

Myringotomy using a microscope was done on the anterior inferior part of the tympanic membrane. The type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected using a special suction device with a collecting bottle, and a ventilation tube was inserted in the tympanic membrane. In the case of bilateral OME, middle ear fluids were collected and analysed separately. The specimen was first standardized. 0.1 ml of 10% citric acid was added, the specimen was centrifuged for 10 minutes and subsequently the original migration reagent was added. Afterwards, the specimen was examined using Peptest, which contains monoclonal antibodies that target pepsin. The result of the Peptest was given as positive (2 lines), negative (1 line) or invalid (no line).

Then, adenoidectomy using a cold instrument was performed. A specimen of adenoids (5x5x5mm) from the area close to the torus tubarius was fixed in formaldehyde and immunohistochemically analysed at the Department of Pathology. Antibody P3635Rb-h (Uscnlife, USA, concentration 1:100) was used as the primary antibody. Antibody N-HistofineSimple Stain MAX PO (Nichirei Biosciences Inc.) was used as the secondary antibody.

Statistical analysis was done using MS Excel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• children with otitis media with effusion

• age 1-7 years

• signing of the informed consent

Exclusion Criteria:

• children with craniofacial abnormalities (Down syndrome, Treacher Collins syndrome, clefts etc.)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Other:
• Restech

• Peptest

• Detection of pepsin in adenoid specimen

Locations

Country	Name	City	State
Czech Republic	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

References & Publications (4)

Jiang A, Liang M, Su Z, Chai L, Lei W, Wang Z, Wang A, Wen W, Chen M. Immunohistochemical detection of pepsin in laryngeal mucosa for diagnosing laryngopharyngeal reflux. Laryngoscope. 2011 Jul;121(7):1426-30. doi: 10.1002/lary.21809. Epub 2011 Jun 6. — View Citation

O'Reilly RC, He Z, Bloedon E, Papsin B, Lundy L, Bolling L, Soundar S, Cook S, Reilly JS, Schmidt R, Deutsch ES, Barth P, Mehta DI. The role of extraesophageal reflux in otitis media in infants and children. Laryngoscope. 2008 Jul;118(7 Part 2 Suppl 116):1-9. doi: 10.1097/MLG.0b013e31817924a3. — View Citation

Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12. — View Citation

Zeleník K, Matoušek P, Urban O, Schwarz P, Stárek I, Komínek P. Globus pharyngeus and extraesophageal reflux: simultaneous pH <4.0 and pH <5.0 analysis. Laryngoscope. 2010 Nov;120(11):2160-4. doi: 10.1002/lary.21147. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of the extraesophageal reflux in children with otitis media with effusion measured with three different methods	Children between 1 to 7 years diagnosed with OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in this prospective study. EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in an adenoid specimen was done immunohistochemically using antibody P3635Rb-h.	2 years	No